| CTRI Number |
CTRI/2023/05/052918 [Registered on: 19/05/2023] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
analysis of flow in kidney blood vessels to predict kidney injury earlier, in adult living donor liver transplant patients |
|
Scientific Title of Study
|
Renal Resistive index as a predictor of acute kidney injury in patients undergoing living donor liver transplantation – a prospective observational study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KAVINANDAN G |
| Designation |
Fellow Liver anaesthesia and critical care |
| Affiliation |
Dr Rela Institute and Medical Centre |
| Address |
Department of Liver Anaesthesia and Critical care, Dr Rela Institute and Medical Centre,No. 07, 3rd floor, CLC works road, Chromepet, Chennai
Dr Rela Institute and Medical Centre,No. 07, CLC works road, Chromepet, Chennai-600044
Chennai
TAMIL NADU
600044
India |
| Phone |
9902770982 |
| Fax |
|
| Email |
kavinandangmk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amal Francis Sam |
| Designation |
Consultant |
| Affiliation |
Dr Rela Institute and Medical Centre |
| Address |
Department of Liver Anaesthesia and Critical care, Dr Rela Institute and Medical Centre,No. 07, 3rd floor, CLC works road, Chromepet, Chennai
Dr Rela Institute and Medical Centre,No. 07, 3rd floor, CLC works road, Chromepet, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
8968163281 |
| Fax |
|
| Email |
amalfsam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amal Francis Sam |
| Designation |
Consultant |
| Affiliation |
Dr Rela Institute and Medical Centre |
| Address |
Department of Liver Anaesthesia and Critical care, Dr Rela Institute and Medical Centre,No. 07, 3rd floor, CLC works road, Chromepet, Chennai
Dr Rela Institute and Medical Centre,No. 07, 3rd floor, CLC works road, Chromepet, Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
8968163281 |
| Fax |
|
| Email |
francisjoseph16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rela Institute snd Medical Centre, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr Rela Institute and Medical Centre |
| Address |
No.07, CLC works road, Chrompet, Chennai, Tamil Nadu |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kavinandan G |
Dr Rela Institute and Medical Centre |
Department Of Liver Anaesthesia and Critical care, No. 07, 3rd floor, CLC works road, Nagappanagar, Chromepet-600044
Chennai
TAMIL NADU |
9902770982
kavinandangmk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rela Institute and Medical Centre, Institutional Ethical committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K769||Liver disease, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. To assess whether RRI could predict acute kidney injury in the post-operative period in patients undergoing living donor liver transplantation |
|
| ExclusionCriteria |
| Details |
1. To find the correlation between trough tacrolimus levels and RRI.
2. To find the association between urea, creatinine, estimated glomerular filtration rate and RRI.
3. To assess whether RRI could predict recovery from acute kidney injury.
4. To assess the changes in RRI and its association with patient outcomes – sepsis, mechanical ventilation, wound infection, length of ICU stay and hospital stay.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| increase in RRI will preceede the changes in creatinine and will help to predict AKI early |
Pre operative day, POST OPERATIVE 01 TO POST OPERATIVE 05 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association between RRI & Tacrolimus trough levels
Association of RRI with blood Urea,s.creat, eGFR
Whether could predict recovery from AKI
|
POST OPERATIVE day 01 to post OPERATIVE day 05 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2023 |
| Date of Study Completion (India) |
30/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/01/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational study to find out the role of measuring renal resistive index in predicting acute kidney injuryin patients undergoing living donor liver transplantation surgeries. The renal resistive index (RRI) is a non-invasive ultrasonographic Doppler tool which measures blood flow velocity in intra-parenchymal renal arteries. Normal values are reported between 0.60 to 0.70 with the difference between both kidneys being mostly less than 5%. Tacrolimus is one of the drugs used in immunosuppressive therapy of organ transplant recipients and its potency has been proven in treating early graft dysfunction, graft loss, acute rejection, new onset diabetes after transplant and hypertension.
Study population includes those who are above 18years of age. Total sample size is 100. These patients RRI is measured pre operatively and follow up til POD 05 along with tacrolimus trough level, renal function biochemical parameters, eGFR, urine output etc.
Our secondary objective is to find the association with tacrolimus trough levels,eGFR along with RRI in predicting AKI. |